Ketamine hydrochloride for Major depressive disorder | Treatment-resistant depression

Inclusion criteria

• {"criterion_text":"- Participant is willing and able to give informed consent for participation in the study.\n- Male and Female, aged 18-70.\n- Women of childbearing potential (WOCBP) must use at least 1 highly effective method of contraception. Highly effective methods of contraception are those which have a failure rate of <1% (when implemented consistently and correctly) and include: Intrauterine device (IUD), Bilateral tubal ligation, bilateral salpingectomy, or bilateral tubal occlusive procedure, Hormonal contraceptives (eg, oral, patch, or injectable), A double-barrier protection method (eg, condom, sponge, or vaginal diaphragm with spermicide cream, foam, or gel); abstinence from heterosexual intercourse is accepted if this is the participant’s usual lifestyle.\n- Diagnosed with major depressive disorder (according to SCID5-CV scale).\n- Affected by treatment resistant depression (defined as at least 2 different antidepressant agents used without success).\n- Adequacy of the score for anesthesia."}

Exclusion criteria

• {"criterion_text":"- Chronic neurological disease.\n- Intellectual disability\n- Contraindications to the electroconvulsive therapy (severe aortic valve stenosis, implantable cardiac defibrillators, uncontrolled hypertension, clinically significant respiratory, renal or hepatic disease, abdominal aortic aneurysm, endocrine disorders, neuromuscular diseases, space occupying brain lesions, stroke in the last 6 months),\n- Contraindications to the electroconvulsive therapy (severe aortic valve stenosis, implantable cardiac defibrillators, implantable electronic devises, uncontrolled hypertension, clinically significant respiratory, renal or hepatic disease, abdominal aortic aneurism, endocrine disorders, neuromuscular disease, space-occupying brain lesions, stroke in the last 6 months).\n- Patients with Alcohol Use Disorder or Substance Use Disorder or Substance Abuse history in the past year,\n- Pregnancy and lactation\n- Cardiovascular conditions\n- Psychiatric Disorders\n- Hepatic impairment\n- Participants with a known hypersensitivity to ketamine or any of its excipients will be excluded from the study\n- Participants with any contraindications to the use of ketamine, such as a history of severe cardiovascular conditions (e.g., uncontrolled hypertension, significant arrhythmias), intracranial hypertension, or severe liver impairment, will also be excluded to prevent potential adverse events."}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is the mean change in depressive symptoms, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS), from baseline to Day 28 (Week 4). This will assess the short-term efficacy of the treatment.","definition_or_measurement_approach":"Mean change in MADRS score from baseline to Day 28 (Week 4); MADRS administered at baseline and Day 28 to assess short-term efficacy."}

Secondary endpoints

• {"endpoint_text":"- The secondary endpoints include the mean change in MADRS scores from baseline to Week 12, which will evaluate the long-term effects of the treatment. Additionally, cognitive outcomes will be assessed at both Day 28 and Week 12 to examine the impact of the treatment on cognitive function.","definition_or_measurement_approach":"Mean change in MADRS score from baseline to Week 12 for long-term effect; cognitive outcomes assessed at Day 28 and Week 12 (specific cognitive measures referenced in documents but not specified in CTIS JSON)."}

Italy

Earliest CTIS Part Ii Submission Date

04-09-2024

Latest Decision Or Authorization Date

09-10-2024

Processing Time Days

35

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

Universita' Vita-salute S. Raffaele

Organisation Type

Educational Institution

Country Of Registered Address

Italy